Dina Shaaban

Experience

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  OPI Pharm

  Sept 2013 - Dec 2014

  IPC Specialist
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  Taisier Med for Surgical Sutures

  Dec 2014 - Nov 2017

  Document Controller

  • Responsible for organizing, handling and implementation of the numerous documentsand records and maintain document control processes for the efficient management andrecording of ISO 13485 medical device management system. • Responsible for the electronic filing and archiving system and technical library for easyto issuance, storage, retrieval and management of documents to internal and externalcustomers. • Preparing of the product technical file (Class III) for the CE certification. • Member of internal audit team,. And following up the corrective and preventive action(CAPA) system through Root Cause analysis (RCA). • Prepare all documents related to MOH registration and regulatory affairs. • Member of Clinical data research team for Clinical Evaluation. • Member of Product risk assessment team. Show less

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  Educational Institution

  Jan 2016 - now

  Freelancer in quality consultation and auditing

  1. Preparation of numerous management systems for ISO 13485:2016, Medical devices -Quality management systems for many Companies. 2. Preparations of the CE Technical files according to [COUNCIL DIRECTIVE 93/42/EEC of 14June 1993 concerning medical devices] for many Companies. 3. preparation of numerous management systems about ISO 9001:2015 4. Preparation of ISO 22000:2005, Food safety management systems5. Preparation ISO 14001:2015, Environmental management systems6. OHSAS 18001, Occupational Health and Safety Management (OHS) Show less

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  Orchidia Pharmaceutical Industries

  Sept 2020 - Apr 2024

  QA RA section head

  • Medical device team leader, responsible for ensuring compliance with ISO/CE regulatory requirements for ophthalmic and non-ophthalmic MDs with both internal and external authorities. This involves preparing CE technical files according to MDD 93/42/EEC, MDR 2017/745, and the new regulation of EDA Regulatory Requirements for new products, as well as reviewing and updating CE of ongoing products.• Responsible for Risk Management (RM) planning and reporting, as well as its updates according to ISO 14971:2019 for medical devices and to ICH Q9 for pharmaceuticals.• Handle communications with notified person for CAR follow-ups, and I'm responsible for the direction and implementation of the company QMS ( ISO 13485:2016, ISO 9001:2015, ISO 14001:2015, ISO 4500:2018, and ISO 17025:2017), quality policy, and procedural implementation.• Optimize quality assurance standards, policies, and Procedures by training staff in QMS and implementing corrective actions.Internalnternal audit team leader, who coordinates internal and external audits in compliance with GMP, CE, and ISO guidelines for fulfilling the audit system objective and the company's Yearly Objectives. • Handle and participate in the external audit assigned to [off-site] for suppliers and sites of toll manufacturing and subcontractors.• Perform periodic reviews for GMP of WHO/MHRA/FDA guidelines updates, and legal regulations by national authorities tabulate in gap analysis format.• Lead supplier qualification team who is responsible for control of supplier adding or changing by following up and collecting all the supplier technical documentations such as quality agreements drafting, MDSD as per relevant system SOPs.• Responsible for the training of the QMS for medical devices and cooperating with all departments in solving problems arising at any stage of the product life cycle, from the designing stage to the packaging and distribution stages.• PRRC (person responsible for regulatory compliance) Show less

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  SchoMedX Academy

  Jul 2023 - now

  Owner and Founder of SchoMedX Academy

  • Led training courses in QA RA field, ISO 13485, risk management, and clinical evaluation at SchoMedX Academy.• Provided consulting services for technical documentation, PMS documentation creation, and audit non-conformances review.• Developed coaching programs for one-to-one meetings and offered consulting within EDA Non CE compliance.

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  K Line Europe GmbH

  May 2024 - Oct 2024

  Compliance Manager

  • Regulatory expertise:• Responsible for ensuring compliance with ISO/CE regulatory requirements for dental medical devices with both internal and external authorities. This involves preparing CE technical files according to MDR 2017/745, FDA's 21 CFR Part 820, Health Canada, TGA (Australia), ISO 13485 and more.• Provide regulatory guidance to project teams to enable accurate decision-making.• Perform periodic reviews for GMP of WHO/MHRA/FDA guidelines updates, and legal regulations by national authorities tabulate in gap analysis format.• Quality Assurance/Management:• track record in developing and sustaining compliant Quality Management Systems (QMS).• Experience with audit processes, CAPA management, and quality improvement methodologies like Lean and Six Sigma.• Strong aptitude for generating, reviewing, and managing compliance documentation.• Ensuring systematic and accurate record-keeping for regulatory audits and reviews.• Proactive updating of documents in response to regulatory shifts• Training Expertise/Interdepartmental Collaboration:• Project Handling/Problem-Solving Skill:• Competence in overseeing concurrent projects with an emphasis on compliance and timelines.• Setting clear project milestones, resource allocation, and progress tracking.• Proactively addressing project challenges and ensuring deliverables.• Advanced analytical skills for interpreting and applying intricate regulatory requirements.• Ability to pinpoint compliance gaps, assess risks, and devise solutions.• Proficiency in root cause analysis and corrective action planning. Show less